parallel randomized trial

DUAL™IV

The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy

Type 2 diabetes (adults)NCT01618162S000164

Design

Randomized: 435
Start year: 2012
Treatment: 26 weeks
Countries: multinational (77 sites)
Sponsor: Novo Nordisk (industry)
Eligibility: adults 18 or older; HbA1c 7.0 to 9.0 percent; BMI 40 or less; SU with or without metformin; insulin and GLP-1 RA naive

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: central
Outcome adjudication: yes
Primary estimand: not stated
Analysis population: full analysis
Missing data: LOCF

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Insulin degludec and liraglutide (IDegLira) subcutaneous once daily titrated IDegLira	sulfonylurea with or without metformin; lifestyle: standard	289	289
A2	Placebo Placebo	sulfonylurea with or without metformin; lifestyle: standard	146	146

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Insulin degludec and liraglutide (IDegLira) subcutaneous once daily titrated A1	Placebo A2
age	mean (years)	60.0	59.4
age	sd (years)	9.6	10.8
asian	percent	18.0	13.7
black	percent	5.5	8.9
bmi	mean (kg/m2)	31.2	32.0
bmi	sd (kg/m2)	4.8	4.5
diabetes duration	mean (years)	9.0	9.3
diabetes duration	sd (years)	5.5	6.5
female	percent	46.7	50.0
hba1c	mean (percent)	7.9	7.9
hba1c	sd (percent)	0.6	0.6
hispanic	n	24	16
hispanic	percent	8.3	11.0
metformin use	percent	89.6	88.4
other fpg	mean (mmol/L)	9.1	9.1
other race other	percent	1.4	1.4
sbp	mean (mmHg)	132.5	132.4
uacr	mean (mg/mmol)	9.4	5.1
uacr	sd (mg/mmol)	30.8	11.7
waist	mean (cm)	106.4	105.9
waist	sd (cm)	13.5	12.7
weight	mean (kg)	87.2	89.3
weight	sd (kg)	18.6	17.5
white	percent	75.1	76.0

Analyses this trial contributes to

Results

36 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

HbA1c change (6 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.45 percent	0.84		289	not stated; full analysis; registry:outcomes
26	A1 vs A2	md	-1.02 percent		-1.18 to -0.87		not stated; full analysis; R0015199:Results
26	A1	change	-1.5 percent	0.8		289	not stated; full analysis; R0015199:Results
26	A1 vs A2	md	-0.78 percent		-1.25 to -0.31		not stated; full analysis; region:india; R0017641:Results
26	A2	change	-0.5 percent	0.8		146	not stated; full analysis; R0015199:Results
26	A2	change	-0.46 percent	0.83		146	not stated; full analysis; registry:outcomes

Body weight change in kilograms (diabetes) (4 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1 vs A2	md	1.37 kg		0.31 to 2.43		not stated; full analysis; region:india; R0017641:Results
26	A1	change	0.5 kg	3.1		289	not stated; full analysis; registry:outcomes
26	A1 vs A2	md	1.48 kg		0.90 to 2.06		not stated; full analysis; R0015199:Results
26	A2	change	-1 kg	2.6		146	not stated; full analysis; registry:outcomes

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	responders	79.2		289	not stated; full analysis; R0015199:Results
26	A1 vs A2	or	11.95	7.22 to 19.77		not stated; full analysis; R0015199:Results
26	A2	responders	28.8		146	not stated; full analysis; R0015199:Results

Level 2 or 3 hypoglycemia (participants) (4 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	120 / 288	not stated; safety; R0015199:Table 2
A1	events	2 / 288	not stated; safety; R0015199:Table 2
A2	events	0 / 146	not stated; safety; R0015199:Table 2
A2	events	25 / 146	not stated; safety; R0015199:Table 2

Level 2 or 3 hypoglycemia (episode rate) (1 lines; O04B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1 vs A2	rate ratio	3.74		2.28 to 6.13		not stated; full analysis; R0015199:Results

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 288	not stated; safety; renal failure acute; registry:adverse_events
	A2	events				0 / 146	not stated; safety; renal failure acute; registry:adverse_events

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 288	not stated; safety; R0015199:Results
	A2	events				0 / 146	not stated; safety; R0015199:Results

Three point MACE (2 lines; O21)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 288	not stated; safety; R0015199:Results
	A2	events				0 / 146	not stated; safety; R0015199:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				14 / 288	not stated; safety; registry:adverse_events
	A2	events				5 / 146	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 289	not stated; randomized; registry:flow
	A2	events				2 / 146	not stated; randomized; registry:flow

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 288	not stated; safety; R0015199:Results
	A2	events				0 / 146	not stated; safety; R0015199:Results

Medullary thyroid carcinoma (2 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 288	not stated; safety; R0015199:Results
	A2	events				0 / 146	not stated; safety; R0015199:Results

Thyroid cancer (any) (2 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 288	not stated; safety; R0015199:Results
	A2	events				0 / 146	not stated; safety; R0015199:Results

Gastroparesis (2 lines; O37A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 288	not stated; safety; impaired gastric emptying; registry:adverse_events
	A2	events				1 / 146	not stated; safety; impaired gastric emptying; registry:adverse_events